JP6676413B2 - Press-through packaging for pharmaceuticals - Google Patents

Description

  The present invention relates to a press-through package for enclosing and storing a drug, and more particularly, to a press-through package in which a lid material is provided with an easy-peeling property in addition to a usual press-through method for taking out a drug.

A press-through package (hereinafter sometimes abbreviated as “PTP”) is used for packaging a drug such as a capsule or a tablet.
Conventionally, for the packaging of medicines, a PTP composed of a container provided with a plurality of pockets for accommodating an object to be accommodated by molding a resin sheet and a lid material provided with a heat bonding layer on one side of an aluminum foil is commonly used. Have been. The lid is bonded to the container by heat sealing, and seals the opening of the pocket. The medicine contained in the pocket portion of the PTP is pushed out by pushing the bulge of the pocket portion with fingers, and the lid material at a position corresponding to the pocket portion is broken, and is taken out.

In such a PTP, it has been reported that aluminum foil fragments may be generated at the time of taking out the medicine, and when taking the medicine, accidentally swallowing the aluminum foil fragments together with the medicine is reported. Therefore, it has been proposed to use paper as the base material of the lid material for the purpose of reducing the load on the human body when the lid material is ingested by mistake (Patent Document 1).
On the other hand, for the elderly, when pushing in the pocket portion of the PTP, there is a concern that troubles such as a case where it is difficult to adjust the force and it is difficult to take out the medicine, and a case where the medicine pops out conversely.
Also, in hospitals, dispensing pharmacies, and the like, taking several tens to several hundreds of drugs a day for a so-called single package in which the drugs are packed in one package for each way of drinking, take out the drugs one by one from the PTP. This is troublesome, and there is a demand to easily remove a large number of drugs at once. Therefore, it has been proposed to provide the PTP with an easy peel function.

Paper tends to have high burst strength due to entanglement between pulp fibers. In addition, it is conceivable that the removal of the medicine is hindered by the burrs coming out from the end of the torn lid material.
Therefore, when paper is used instead of the aluminum foil as the base material of the lid material, the ease of taking out the medicine (press-through suitability) when the pocket portion is pushed out to take out the medicine is inferior.
To solve such a problem, a PTP cover in which oxidized pulp or oxidized cellulose is used as a raw material for the paper base of the cover material, and the number of times of folding measured according to the folding strength test method using an MIT tester is 5 times or less. A material has been proposed (Patent Document 2).
However, the PTP lid material does not have sufficient paper strength to withstand easy peeling, and thus has low suitability for easy peeling. For example, when the PTP lid is to be peeled from the container by the easy peel method, the lid is easily broken. Further, since the cellulose fibers are embrittled, there is a concern that dust may be generated during the extrusion of the drug.

As a PTP that has both a press-through function and an easy-peel function, a laminated material of a paper base material and an aluminum foil layer is used as the base material of the cover material, and only the paper base of the cover material is cut at the position corresponding to the pocket. Is proposed in which the peel strength between the container and the heat bonding layer of the lid material is within a specific range (Patent Document 3).
However, since the processing is complicated and the lid material includes an aluminum foil layer, the effect of reducing the load on the human body at the time of accidental ingestion of the lid material is insufficient. Furthermore, since the cut is provided in the paper base material in advance, there is a possibility that the next pocket portion may be opened when the pocket portions are pushed in to take out the objects one by one.

JP 2001-278337 A JP 2001-301810 A JP-A-2003-63558

  An object of the present invention is to provide a pharmaceutical PTP having a substrate made of paper and having excellent press-through suitability and easy peel suitability.

In order to solve the above problems, the present invention has adopted the following configurations.
[1] A drug press-through package comprising a container and a lid material, the container having a pocket portion for containing a medicine and a flange portion joined to the lid material, wherein the lid material and the flange are provided. A thermal adhesive layer between the first and second portions, the lid member has a paper substrate, and the paper substrate is provided on a base paper made of pulp and at least a surface of the base paper on the side of the heat bonding layer. And a coating layer containing a polyacrylamide resin, wherein the pulp constituting the base paper has a freeness of 600 mL or less measured in accordance with JIS P 8121-2: 2012, and is provided on the surface on the side of the heat bonding layer. was the content of the polyacrylamide resin in the coating layer is 0.1~10.0g / m ^2, the agent for press-through, wherein the basis weight of the paper substrate is 18 g / m ² or more Packaging.
[2] The pharmaceutical press-through package according to [1], wherein the pulp constituting the base paper has the following irregular freeness of 50 to 500 mL.
Irregular freeness: Measured according to JIS P 8121-2: 2012 except that the solid content concentration of the pulp suspension was changed from 0.30% ± 0.01% to 0.030% ± 0.001%. Freeness.
[3] The pharmaceutical press-through package according to [1] or [2], wherein the paper substrate has a basis weight of 50 g / m ² or less.
[4] The pharmaceutical press-through packaging according to any one of [1] to [3], wherein the container is a molded product of a container base sheet, and the container base sheet is a transparent thermoplastic resin sheet. body.
[5] The container base sheet is (a) a polypropylene sheet, (b) a polyvinyl chloride sheet, (c) a cyclic polyolefin sheet, and (d) two or more sheets of the above (a) to (c). (E) one or more sheets selected from the group consisting of (a) to (d) and one or more sheets selected from the group consisting of polyvinylidene chloride, polychlorotrifluoroethylene and polyethylene The pharmaceutical press-through package according to [4], which is a sheet obtained by laminating the above sheet or coating the polymer.
[6] The lid can be peeled off from the container by an easy peel method, and when the lid material is peeled off by the easy peel method, the heat bonding layer is formed on the paper base at a portion in contact with the flange portion. The pharmaceutical press-through package according to any one of [1] to [5], wherein the lid member and the flange portion are bonded so as to be separated from a material and remain on the flange portion side.

  ADVANTAGE OF THE INVENTION According to this invention, the base material is paper and the pharmaceutical PTP which has excellent press-through suitability and easy peel suitability can be provided.

BRIEF DESCRIPTION OF THE DRAWINGS It is sectional drawing which shows 1st embodiment of PTP of this invention typically. FIG. 2 is a cross-sectional view schematically showing a state in which a lid material is peeled off from a container by an easy peel method in the PTP shown in FIG. 1.

<PTP for drugs>
A PTP (press-through package) for a medicine of the present invention includes a container and a lid material, and the container includes a pocket part for containing a medicine and a flange part joined to the lid material. .

Hereinafter, the pharmaceutical PTP of the present invention will be described with reference to the accompanying drawings and embodiments.
FIG. 1 is a sectional view schematically showing a first embodiment of the pharmaceutical PTP of the present invention. FIG. 1 shows a state in which a medicine is enclosed in the medicine PTP 10 of the present embodiment.
The pharmaceutical PTP 10 of the present embodiment includes a container 1, a lid member 3, and a heat bonding layer 5. The heat bonding layer 5 is disposed between the container 1 and the lid 3.
The container 1 includes a plurality of pockets 15 for accommodating the medicine 19, and a flange 17 provided around openings of the plurality of pockets 15 and joined to the lid 3 via the thermal adhesive layer 5. Prepare.
The surface of the flange portion 17 on the side of the lid 3 is flat, and is in close contact with the lid 3.
Each of the plurality of pocket portions 15 is formed so as to protrude from the surface of the flange portion 17 on the side opposite to the lid member 3 side, and has a recess for accommodating the medicine 19 inside the protruding portion. The concave portion is opened on the surface of the flange portion 17 on the side of the lid member 3, and the opening is sealed with the lid member 3 via the heat bonding layer 5, thereby forming a space for accommodating the medicine 19.

(container)
The container 1 is not particularly limited, and may be a known container for PTP, and includes, for example, a molded product of a container base sheet.
The container base sheet is not particularly limited, but a transparent thermoplastic resin sheet is preferable, and examples thereof include the following. In addition, various known materials can be used.
(A) polypropylene (PP) sheet,
(B) polyvinyl chloride (PVC) sheet,
(C) a cyclic polyolefin (COC) sheet,
(D) a laminated sheet obtained by laminating any two or more sheets of the above (a) to (c); and (e) one or more sheets selected from the group consisting of the above (a) to (d) A sheet obtained by laminating or coating a sheet of one or more polymers selected from vinylidene chloride (PVDC), polychlorotrifluoroethylene (PCTFE) and polyethylene (PE).
Examples of the sheet (e) include Aklar (registered trademark) (PVC / PCTFE) and Sumilite (registered trademark) VSL-4610N (PVC / PVDC / PE / PVDC / PVC).

  The container 1 can be manufactured, for example, by forming a plurality of pockets 15 in the above-described container base sheet. The method of forming the pocket portion 15 is not particularly limited, and examples thereof include a plug assist molding method, a vacuum molding method, a pressure molding method, a vacuum pressure molding method, and a hot pressing method.

(Lid material)
The lid 3 has a paper base 31.
The paper substrate 31 includes a base paper made of pulp, and a coating layer provided on at least a surface of the base paper on the side of the heat bonding layer 5. The coating layer contains a polyacrylamide resin.
In the paper substrate 31, the coating layer usually exists at least partially below the surface of the base paper. Part of the coating layer may be present on the surface of the base paper.
Therefore, the base paper constituting the paper base material 31 usually contains polyacrylamide resin derived from the coating layer. The concentration of the polyacrylamide resin in the base paper (concentration in the thickness direction of the base paper) may be uniform, or may have a concentration gradient such that the concentration decreases from the surface of the base paper toward the inside.

  Examples of the pulp constituting the base paper include wood pulp and non-wood pulp. Examples of the wood pulp include conifer pulp and hardwood pulp, and any of them may be used. The cooking method and the bleaching method are not particularly limited. Non-wood pulp includes hemp pulp, kenaf pulp, bamboo pulp and the like. These pulp may be used individually by 1 type, and may be used in combination of 2 or more type.

The degree of beating of the pulp constituting the base paper is 600 mL or less, and preferably 350 mL or less, as a freeness (hereinafter, also referred to as “standard freeness”) measured according to JIS P8121-2: 2012.
Generally, regarding the relationship between beating of pulp and paper strength, it is difficult to obtain paper strength in a state in which beating is not so much promoted, because the pulp fibers are weakly entangled and there are few points of inter-fiber bonding (hydrogen bonding). This is considered to be the reason, and a certain amount of beating improves paper strength. If the standard freeness of the pulp is equal to or less than the above upper limit, the paper strength of the base paper, and eventually the paper base material 31, is sufficiently high, and the easy peelability of the cover material 3 is excellent.

The beating degree of the pulp is more preferably 50 to 500 mL, and even more preferably 100 to 500 mL, as the following irregular freeness.
Irregular freeness: Measured according to JIS P 8121-2: 2012 except that the solid content concentration of the pulp suspension was changed from 0.30% ± 0.01% to 0.030% ± 0.001%. Freeness.
Since the amount of pulp used for measurement is one-tenth of the standard freeness, the irregular freeness is suitable for evaluation in a state where beating has progressed to a certain extent than the standard freeness. For example, 770 mL of the irregular freeness is about 380 mL of the standard freeness.

When the irregular freeness of the pulp is within the above range, both excellent easy peel suitability and excellent press-through suitability can be achieved.
As mentioned above, the paper strength is improved by a certain degree of pulp beating. However, if beating is excessively performed, on the contrary, the fiber itself is damaged and paper strength is reduced.
If the irregular freeness is equal to or less than the upper limit of the above range, the paper strength is reduced, the bursting strength of the paper base material 31 is reduced, and the occurrence of fluff from the torn edge is also less likely to occur. can get. However, it is considered that material breakage at the time of peeling by the easy-peel method is relatively unlikely to occur because the entanglement between fibers is also advanced.
When the irregular freeness is equal to or more than the lower limit of the above range, an excessive decrease in paper strength is unlikely to occur, and easy peelability is excellent. In addition, the time required for beating is not long, the dewatering property during papermaking is good, and the operation efficiency is excellent.

The base paper may contain a fiber material other than pulp, such as rayon fiber, nylon fiber, or other heat-sealing fiber, as an auxiliary material.
The base paper may contain various internal chemicals for papermaking, a retention aid, an antifoaming agent, a filler, a coloring agent, and the like. Examples of the internal additives include various fixing agents such as sizing agents, paper strength agents, wet paper strength agents, sulfate bands, and cationized starch.

Base paper can be produced by making a papermaking raw material containing a pulp slurry.
Pulp slurry is obtained by beating pulp in the presence of water. An internal chemical for papermaking or the like is added to the pulp slurry obtained by beating to prepare a papermaking raw material.
The pulp beating method and beating apparatus are not particularly limited, but a double disc refiner (DDR) having high beating efficiency is preferably used.
Papermaking of the papermaking raw material can be performed by a standard method.
The basis weight of the base paper is set according to the basis weight of the paper base material 31 and the applied amount of the primer.
The beating degree (standard freeness, irregular freeness) of the pulp used in the production of the base paper is equal to the beating degree of the pulp constituting the base paper.

The coating layer contains a polyacrylamide resin.
Polyacrylamide resin is a polymer having (meth) acrylamide units. “(Meth) acrylamide” is a general term for acrylamide and methacrylamide. The polyacrylamide resin may have either an acrylamide unit or a methacrylamide unit, or may have both. The polyacrylamide resin may have other units other than the (meth) acrylamide unit.

Examples of the polyacrylamide resin include an anionic polyacrylamide resin, a cationic polyacrylamide resin, an amphoteric polyacrylamide resin, and a nonionic polyacrylamide resin. Each of these can be used as a known paper strength agent in the papermaking field, for example, those described in JP-A-2002-317393, JP-A-2004-231901, JP-A-2014-205938 and the like. Can be
One type of polyacrylamide resin may be used alone, or two or more types may be used in combination. In terms of availability, an anionic polyacrylamide resin is preferred.
The anionic polyacrylamide resin contains an anionic functional group such as a carboxy group, a sulfonic acid group, a phosphoric acid group, and a salt thereof. For example, (meth) acrylamide and an anionic functional group-containing monomer (such as acrylic acid) Copolymers and partial hydrolysates of poly (meth) acrylamide are exemplified.

The polyacrylamide resin preferably has a weight average molecular weight (Mw) of 50,000 to 500,000, more preferably 50,000 to 300,000.
When the mass average molecular weight of the polyacrylamide resin is within the above range, the effect of suppressing fluffing on the surface of the paper base material without increasing the burst strength measured according to ISO 2758 of the base paper is more excellent. When the mass average molecular weight is equal to or more than the lower limit of the above range, the effect of suppressing the fluffing of the surface of the cover material 3 (paper base material 31) when the heat bonding layer 5 is peeled off is easily obtained. When the mass average molecular weight is equal to or less than the upper limit of the above range, the viscosity of the coating liquid for forming the coating layer (coating layer coating described later) is sufficiently low to apply, and the preparation and application of the coating layer coating are performed. Is easy. In addition, the concentration of the polyacrylamide resin in the coating for the coating layer can be increased, and a desired coating amount can be easily obtained. If the weight average molecular weight exceeds 500,000, it is used as an internal paper strengthening agent, but the viscosity of the solution increases, making it difficult to prepare and apply a coating for a coating layer, and to obtain a satisfactory coating amount. Hateful.
The mass average molecular weight of the polyacrylamide resin is a value in terms of polyethylene oxide measured by gel permeation chromatography (GPC).

The coating layer may contain components other than the polyacrylamide resin, if necessary, as long as the effects of the present invention are not impaired.
Examples of other components include, but are not limited to, starch, modified starch, polyvinyl alcohol, modified polyvinyl alcohol, hydroxyethyl cellulose, methyl cellulose, carboxymethyl cellulose, gelatin, casein, gum arabic, diisobutylene / maleic anhydride copolymer, and the like. Water-soluble polymer compounds such as coalesced salts, styrene / maleic anhydride copolymer salts, styrene-butadiene copolymer emulsions, acrylate copolymer emulsions, urethane resins, urea resins, styrene-acrylic resin emulsions, ethylene- Examples include aqueous polymer compounds such as acrylic resin emulsions, release agents, defoamers, dispersants, wetting agents, colored dyes, colored pigments, and white pigments. These may be used alone or in combination of two or more.

  The content of the polyacrylamide resin in the coating layer is preferably from 50 to 100% by mass, more preferably from 80 to 100% by mass, based on the total mass (100% by mass) of the coating layer. When the content of the polyacrylamide resin is equal to or more than the lower limit of the above range, easy peel suitability is good.

In the paper base material 31, the content of the polyacrylamide resin in the coating layer provided on the surface on the side of the heat bonding layer 5 is 0.1 to 10.0 g / m ² , and 0.2 to 3.0 g / m ^{2. 2} is more preferred. If the content of the polyacrylamide resin per unit area of the coating layer on the surface on the side of the heat bonding layer 5 is equal to or more than the lower limit of the above range, the paper base 31 (lid material 3) and the heat bonding layer 5 can be easily peeled. Are peeled off satisfactorily, and fluffing of the surface of the paper base material 31 and breakage of the base material hardly occur. When the coating amount is equal to or less than the upper limit of the above range, the rupture strength of the lid member 3 is suppressed to be low, and press-through suitability is excellent.

In the case where a coating layer is provided on the surface of the paper substrate 31 opposite to the heat bonding layer 5 side, the content of the polyacrylamide resin in the coating layer is not particularly limited, but is preferably 10.0 g / m ² or less. , 0.1 to 5.0 g / m ² , more preferably 0.2 to 3.0 g / m ² . When the coating amount is equal to or less than the upper limit of the above range, the rupture strength of the lid member 3 is suppressed to be low, and press-through suitability is excellent.

The basis weight of the paper substrate 31 is 18 g / m ² or more, and preferably 20 g / m ² or more. When the basis weight of the paper base material 31 is equal to or more than the lower limit, a strength that can endure easy peeling is easily obtained, and the base material is less likely to be broken at the time of peeling.
Although the basis weight of the upper limit of the paper substrate 31 is not particularly limited, it is preferably 50 g / ^{m 2} or less, more preferably ^{40g / m 2, 35g / m} 2 or less is more preferred. When the basis weight of the paper base material 31 is equal to or less than the upper limit value, the burst strength of the lid material 3 can be suppressed to be low, the force required to extrude the medicine from the PTP pocket portion is small, and the press-through suitability is excellent. .
The grammage of the paper base material 31 is measured according to JIS P 8124: 2011. The same applies to the basis weight of the base paper.

Density of the paper substrate 31 is preferably 0.95~1.30g / cm ^3, more preferably 1.00~1.25g / cm ^3. When the density of the paper base material 31 is equal to or more than the lower limit, press-through suitability is more excellent. When the density of the paper base material 31 is equal to or less than the above upper limit, the ease peelability is more excellent.
The density of the paper base material 31 is determined by measuring the thickness in accordance with JIS P 8118: 1998 and calculating from the measured values of the thickness and the basis weight.

The paper base material 31 can be manufactured by applying a coating liquid containing polyacrylamide resin (hereinafter, also referred to as “coating material for coating layer”) to at least one surface of the base paper and drying to form a coating layer. .
When the coating material for the coating layer is applied to one surface of the base paper, the coating material for the coating layer is applied to the surface on which the heat bonding layer 5 is laminated.

The coating for the coating layer usually contains a liquid medium.
As the liquid medium, those which dissolve the polyacrylamide resin are preferable, and for example, water is mentioned.
The coating material for the coating layer may contain the other components described above as necessary.

  The content (concentration) of the polyacrylamide resin in the coating material for the coating layer is preferably from 50 to 100% by mass, more preferably from 80 to 100% by mass, based on the total solid content (100% by mass) in the coating material for the coating layer. . The total solid content is the total amount excluding the liquid medium from the primer and is the sum of the polyacrylamide resin and other components. The content of the polyacrylamide resin with respect to the total solid content is equal to the content of the polyacrylamide resin with respect to the total mass of the coating layer.

The amount of the coating for the coating layer applied to the base paper is set according to the amount of the polyacrylamide resin.
The coating amount of the coating material for the coating layer on the side of the base paper on which the heat bonding layer 5 is laminated is 0.1 to 10 g / m ² in terms of the amount of the polyacrylamide resin, and 0.2 to 3 g / m ² . 0 g / m ² is more preferred. The applied amount of the undercoating agent in terms of the amount of the polyacrylamide resin is equal to the content of the polyacrylamide resin in the coating layer.

When the coating material for the coating layer is applied to the surface of the base paper opposite to the side on which the thermal adhesive layer 5 is laminated, the amount of the coating is not particularly limited, but is 10.0 g in terms of the amount of polyacrylamide resin. / M ² or less, preferably 0.1 to 5.0 g / m ² , more preferably 0.2 to 3.0 g / m ² .

The method for applying the coating material for the coating layer is not particularly limited, and various known wet coating methods can be used. For example, it can be carried out by using an on-machine size press of a paper machine, a transfer roll coater (such as a Simsizer or a gate roll coater), or a spray device. In the off-machine, a general coating device such as a blade coater, an air knife coater, a roll coater, a reverse roll coater, a simsizer, a gate roll coater, a bar coater, a curtain coater, a slot die coater, a gravure coater, a champlex coater , A brush coater, a two-roll coater, a bill blade coater, a short dwell coater, or the like.
In consideration of operability and productivity, the application and drying of the coating material for the coating layer is preferably performed on-machine. Therefore, the type of the paper machine for making the base paper is not particularly limited, such as a fourdrinier paper machine, a short net paper machine, a circular net paper machine, or the like, but is provided with an on-machine coating machine. It is preferable to use

Usually, at least a part of the applied coating material for the coating layer soaks into the base paper, and the base paper after application contains a polyacrylamide resin. When a part of the coating material for the coating layer penetrates into the base paper, the coating material for the coating layer that has not soaked is dried on the coating surface to form a layer containing polyacrylamide resin on the coating surface of the base paper (hereinafter, referred to as A "surface resin layer" is also formed.
The paper substrate 31 may or may not have a surface resin layer on the base paper application surface. Even without a surface resin layer, the surface of the base paper and its vicinity are impregnated with the polyacrylamide resin, so that excellent easy peel suitability can be obtained. The presence or absence of the surface resin layer can be confirmed by pyrolysis GCMS (gas chromatography mass spectrometry) or the like by shaving the surface and the middle layer with a razor or the like.
The concentration of the polyacrylamide resin in the base paper (concentration in the thickness direction of the base paper) may be uniform, or may have a concentration gradient such that the concentration decreases from the surface of the base paper toward the inside.

  Examples of the method for forming the surface resin layer include a method using a transfer roll coater such as a gate roll coater, and a method for increasing the content of polyacrylamide resin in the coating material for a coating layer. When using a transfer roll coater, the coating for the coating layer is less likely to soak into the base paper than when using a size press device, so that the surface resin layer is easily formed and the concentration gradient of the polyacrylamide resin is easily formed as described above. Tend. In addition, as the content of the polyacrylamide resin in the coating for the coating layer is larger, the viscosity of the coating for the coating layer is higher, and the coating for the coating layer is less likely to soak into the base paper, and the surface resin layer is easily formed, A concentration gradient of the polyacrylamide resin as described above tends to be easily formed.

(Heat bonding layer)
The material constituting the thermal bonding layer 5 is not particularly limited, and various materials exhibiting thermal adhesiveness can be used, and are appropriately selected according to the material of the container to which the thermal bonding layer 5 is thermally bonded and the thermal bonding conditions. .
Examples of the material exhibiting thermal adhesiveness include an ethylene-vinyl acetate copolymer, an ethylene- (meth) acrylic acid copolymer, an acrylate polymer, polyethylene, and a polyethylene-polybutene mixture. These may be used alone or in combination of two or more.

The heat bonding layer 5 can be formed, for example, by applying a heat sealant containing the above-described material and a liquid medium to one surface of the lid material 3 (paper base material 31) and drying.
The heat sealing agent may be an aqueous heat sealing agent in which the above-mentioned material is dissolved or dispersed in water, or a solvent-based heat sealing agent in which the above-mentioned material is dissolved in a solvent.
Examples of the water-based heat sealant include an ethylene-vinyl acetate copolymer emulsion, an ethylene- (meth) acrylic acid copolymer emulsion, an acrylate polymer emulsion, a polyethylene emulsion, a polyethylene-polybutene mixed emulsion, and a polyvinyl chloride. Emulsions, polyvinyl acetate emulsions, polypropylene emulsions and the like. Among these, ethylene-vinyl acetate copolymer emulsion, acrylate ester emulsion, polyethylene emulsion, and polypropylene emulsion exhibit stable peeling force and do not increase the burst strength measured according to ISO 2758. This is preferable because the effect of suppressing fluffing on the material surface is high.

The method for applying the heat sealant is not particularly limited, and can be performed by using various known wet coating methods. For example, a method similar to the method of applying the coating material for the coating layer may be used.
Regarding the drying equipment, in the direct application method using a cylinder dryer, there is a possibility that the dryer and the canvas may be contaminated. Therefore, drying using an air dryer or an infrared heater that does not come into contact with the application surface is preferable.
Further, it is preferable to pass a cooling roll between the drying step and the winding step.

The basis weight (dry application amount of the heat sealing agent) of the heat bonding layer 5 is not particularly limited, and is appropriately selected according to the material of the adherend to which the heat bonding layer 5 is bonded and the heat sealing conditions. Preferably 0.1 to 30 g / ^{m 2,} more preferably from 0.5 to 20 g / ^{m 2.} When the basis weight of the thermal bonding layer 5 is 0.1 g / m ² or more, a satisfactory thermal bonding force is easily obtained. For example, when the medicine 19 is accommodated in the pocket portion 15 of the container 1 and the medicine portion 19 is pushed out by pushing the pocket portion 15 in a state where the flange portion 17 of the container 1 and the lid member 3 are joined via the thermal adhesive layer 5, The lid is difficult to peel off. If the basis weight of the thermal bonding layer 5 is 30 g / m ² or less, the paper substrate 31 is less likely to break during easy peeling. Further, the heat bonding layer 5 does not easily exhibit spinnability, and contamination of the accommodated object is unlikely to occur.

In the drug PTP 10, it is preferable that the flange portion 17 of the container 1 and the lid member 3 are bonded so that the lid member 3 can be separated from the container 1 by an easy peel method.
Further, in this case, when the lid member 3 is peeled off by the easy peel method, the bonding between the flange portion 17 and the lid member 3 is performed at a portion in contact with the flange portion 17 as shown in FIG. It is preferable that the bonding is performed so that a part of the adhesive layer 5 is separated from the paper base material 31 and remains on the flange portion 17 side.
If the heat bonding layer 5 remains on the flange portion 17 side during peeling, the heat bonding layer 5 remaining on the paper base 31 side prevents the paper base 31 from fluffing.
Whether or not the thermal adhesive layer 5 remains on the flange portion 17 side during peeling depends on the amount of the polyacrylamide resin applied on the surface of the paper base material 31 on the thermal adhesive layer 5 side, when the lid material 3 is bonded to the flange portion 17. It can be adjusted by the heat bonding conditions (heating temperature, pressure, time, etc.), the combination of the material forming the heat bonding layer 5 and the material of the adherend, and the like.

In the drug PTP 10, the burst strength of the laminate of the lid material 3 and the heat bonding layer 5 measured according to ISO 2758 is preferably 40 to 200 kPa, more preferably 50 to 150 kPa, and more preferably 60 to 130 kPa. More preferred.
When the burst strength of the laminate is 200 kPa or less, the force required to push in the pocket portion 15 to push out the thermal adhesive layer 5 and the lid member 3 to take out the drug 19 does not increase, and even a weak person bears the burden. Is small. Further, the degree of application of the force is easy to adjust, and the thermal adhesive layer 5 and the lid 3 can be pushed and broken without causing the medicine 19 to fly out when the force is applied. In addition, the lid material 3 is not easily attached to the taken-out drug 19, and the lid material 3 is not easily ingested by taking such a drug. In addition, since the force required to push through the thermal bonding layer 5 and the lid 3 is small, the drug 19 is less likely to be deformed or cracked when the thermal bonding layer 5 and the lid 3 are pushed through. In particular, when the drug 19 is a capsule containing a granular drug, deformation of the capsule may hinder extrusion.
When the burst strength is 40 kPa or more, the paper has sufficient strength to withstand easy peeling, and the paper base material 31 is not easily broken at the time of peeling. Further, the medicine 19 is hardly pushed out by a small impact, and the handling of the PTP becomes easy.
The burst strength of the laminate is determined by the freeness (standard freeness, irregular freeness) of the pulp constituting the paper base material 31, the basis weight of the paper base material 31, the content of the polyacrylamide resin in the coating layer (application of the coating material for the coating layer). Amount), the basis weight of the thermal bonding layer 5 and the like.

The peel strength between the lid member 3 and the container 1 is not particularly limited because the suitable range varies depending on the above-mentioned bonding conditions, the bonding method (plain format, roll), and the shape of the heating member surface (plain, embossed). For example, the following peel strength is preferably 20 to 700 N / m, and more preferably 30 to 450 N / m. If the peel strength is equal to or more than the lower limit of the above range, the lid 3 is hardly peeled when the medicine 19 is taken out by pushing the pocket portion 15. When the peel strength is equal to or less than the upper limit of the above range, peeling can be performed without destruction of the substrate during peeling by the easy peel method.
Peel strength: Each end of the lid 3 of the PTP 10 for medicine and the end of the container 1 cut to a width of 15 mm according to JIS P 8113: 2006 using a tensile tester (for example, Tensilon RTC-1250A, manufactured by Orientec). Peel strength measured at a peeling rate of 300 mm / min by a 180 ° peel method after chucking the part.

(Method of manufacturing PTP)
The pharmaceutical PTP 10 can be manufactured, for example, by a manufacturing method including the following steps (α1) to (α4).
(Α1) a step of obtaining a pulp slurry by beating pulp in the presence of water, adding an internal chemical for papermaking to the pulp slurry, preparing a papermaking raw material, and forming the papermaking raw material to obtain a base paper .
(Α2) a step of producing a paper base material 31 by applying a coating material for a surface resin layer on at least one surface of the base paper and drying it, and obtaining a lid material 3.
(Α3) A heat-sealing agent is applied to one surface of the lid material 3 (the surface where the applied amount of polyacrylamide resin is 0.1 to 10.0 g / m ² ) and dried to form the heat bonding layer 5. Obtaining a heat-sealed sheet.
(Α4) The medicine 19 is stored in the pocket portion 15 of the container 1, and the heat seal sheet is placed in the container 1 so that the heat bonding layer 5 side faces the container 1 and the opening of the pocket portion 15 is sealed. A step of superimposing and thermally bonding to obtain a pharmaceutical PTP 10.

Steps (α1) to (α3) can be performed according to the above-described procedures.
The drug 19 is not particularly limited and includes, for example, tablets (ordinary tablets, orally disintegrating tablets, chewable tablets), pills, suppositories, capsules (hard carcel, soft capsules) and the like.
The thermocompression bonding conditions in the step (α4) are not particularly limited.

(Effects)
Conventionally, when the base material of the cover material is mainly paper, it has been difficult to achieve both excellent easy peel suitability and excellent press-through suitability.
In the chemical PTP 10, the cover material 3 has a coating layer containing a polyacrylamide resin on at least the surface of the specific base paper on the side of the heat bonding layer 5, and the content and the basis weight of the polyacrylamide resin are each a specific amount. Because of having the paper base material 31, excellent easy peel suitability and press-through suitability can both be achieved. For example, when the lid member 3 is peeled off from the container 1, destruction of the paper base material 31 and fluffing of the surface hardly occur. Further, it is possible to push the pocket portion 15 with sufficiently small force to break the lid member 3 and take out the medicine 19.
Since the paper base material 31 is not easily torn, when the lid material 3 is peeled off from the container 1 by the easy peel method, the entirety can be peeled at once. Further, since fluffing and peeling of paper pieces are suppressed, it is possible to prevent fibers dropped from the fluffed portion and peeled paper pieces from adhering to the container 1 and the medicine 19. Therefore, when taking out the medicine 19 taken out, it is possible to prevent the attached fiber or paper piece from being swallowed by mistake.
In addition, since the lid 3 is mainly made of paper, the load on the human body when the lid is accidentally swallowed is smaller than that in the case of using the conventional aluminum foil. Further, by being sealed with the heat sealing agent, foreign substances such as dust can be prevented from being mixed.
Therefore, the pharmaceutical PTP 10 is extremely useful in practice.

By having a coating layer containing a polyacrylamide resin on the surface of the paper base material 31 on which the heat bonding layer 5 is laminated, the cover material 3 (paper base material 31) is broken when the cover material 3 is peeled from the container 1. The reason why the fluff on the surface and the fluff on the surface and the falling off of the paper piece from the surface can be suppressed is considered as follows.
Polyacrylamide resin forms a hydrogen bond between an amide group in the molecule and a hydroxyl group in a cellulose or hemicellulose molecule or between the amide group of the polyacrylamide resin itself, and acts as a hydrogen bond between pulp fibers. Increase the number of bonds. Thereby, the bonding of the network of the pulp fibers is strengthened, and it is possible to prevent the pulp fibers from being taken into the heat bonding layer 5 peeled from the paper base material 31 when the lid material 3 is peeled from the container 1.
Polyacrylamide resins, water-soluble polymers such as polyvinyl alcohol and hydrophobized starch are known as paper strength agents and the like in the papermaking field.According to the study of the present inventors, polyacrylamide resins are other Compared to a water-soluble polymer, it is more effective in suppressing the above-described substrate destruction and fluffing.
In addition, the polyacrylamide resin has a lower aqueous solution viscosity and better stability than the other water-soluble polymers (the aqueous solution is less likely to gel). Therefore, the concentration of the polyacrylamide resin can be increased while ensuring sufficient coatability. When the concentration of the polyacrylamide resin in the surface resin layer is high, the coating amount per one surface is likely to be 0.1 g / m ² or more.
Further, the polyacrylamide resin hardly increases the burst strength (measured according to ISO2758) of the base paper. Therefore, it is possible to enhance the ease peel suitability without impairing the press-through suitability of the base paper.

The embodiment of the drug PTP of the present invention has been described above, but the present invention is not limited to the above embodiment. Each configuration in the above-described embodiment and a combination thereof are merely examples, and addition, omission, replacement, and other changes of the configuration are possible without departing from the spirit of the present invention.
For example, the lid material constituting the PTP for medicine may be any material having the paper substrate 31 and is not limited to the lid material 3.
For example, the lid member may have another layer on the surface of the paper base material 31 on the side of the heat bonding layer 5 in addition to the paper base material 31. Other layers include, for example, a water vapor barrier layer, an oxygen barrier layer, a print layer, a printability improving layer, an overprint layer, a light shielding layer, and the like. The other layer included in the lid member may be a single layer or two or more layers. A printing layer may be provided on the surface of the paper base material 31 opposite to the heat bonding layer 5 side. An overprint layer may be further provided on the print layer.
The container 1 may have a printed layer on at least one side. An overprint layer may be further provided on the print layer.
Further, a mirror image design can be printed so as to be visible from the container side, and a mirror image design, a solid white pattern, and a normal image design can be superimposed and printed so that individual designs can be visually recognized from both sides.

  Hereinafter, the present invention will be described specifically with reference to examples. Note that the present invention is not limited to these examples.

<Example 1>
[Manufacture of paper base material]
A mixture of 80% softwood bleached kraft pulp (NBKP) and 20% hardwood bleached kraft pulp (LBKP) is beaten by DDR so that the irregular freeness (pulp collection amount 0.3 g / L) becomes 200 mL, and pulp slurry I got To the pulp slurry, as an internal additive, 1% of a sulfuric acid band in absolute dryness and 0.07% of a drainage improver (trade name: SOFTOL (registered trademark) 3503, manufactured by Yuka Sangyo Co., Ltd.) are added to the pulp mass. Thus, a papermaking raw material was obtained. The raw material for papermaking is made with a Fourdrinier paper machine to obtain a base paper, and the coating material for the coating layer (A) described below is coated with a gate roll coater attached to the paper machine so that the coating amount after drying on one side is zero. 0.4 g / m ² (0.8 g / m ^{2 on} both sides), dried and smoothed with an off-machine calender to obtain a basis weight of 30 g / m ² and a density of 1.05 g / cm ^3. Was obtained.
Coating material for coating layer (A): An aqueous solution of anionic polyacrylamide resin (mass average molecular weight: 200,000) (Polymer set (registered trademark) 512 manufactured by Arakawa Chemical Industry Co., Ltd.) is diluted with water, and the concentration of anionic polyacrylamide resin is 10% by mass. % Adjusted).

[Manufacture of heat seal sheet]
Using a bar coater, an ethylene-vinyl acetate copolymer emulsion-based heat sealant (trade name: EA-H700, manufactured by Toyo Ink Co., Ltd.) was applied on one side of the paper substrate obtained above, after drying. Was applied and dried so as to be 1.4 g / m ² to form a heat bonding layer, and a heat seal sheet was obtained.

[Manufacture of drug-containing PTP]
The following containers were prepared.
Container: Using a polyvinyl chloride resin film sheet having a thickness of 250 μm, 10 drug storage sections (pocket sections) having a diameter of 10 mm and a depth of 5 mm (5 × 2 rows) were formed on the sheet by a PTP filling and packaging machine. It was provided by an air assist plug molding method.
A medicine (tablet diameter: 9.5 mm, thickness: 4 mm) is filled in the pocket portion of the container, and the heat-sealing sheet (lid material with a heat-adhesive layer) obtained above is brought into contact with the container on the side of the heat-adhesive layer. Then, the lid material and the container were thermocompression-bonded to each other at a hot roll-type bonding section heated only by the lid material-side roll (lattice-shaped embossing roll), thereby producing a PTP in which the above-mentioned drug was sealed.

<Example 2>
In the production of the paper base material of Example 1, a paper base material, a heat seal sheet and a drug-containing PTP were sequentially manufactured in the same manner as in Example 1 except that the irregular freeness of the pulp was changed to 460 mL.

<Example 3>
In the manufacture of the paper base material of Example 2, except that the basis weight of the base paper was reduced to 25 g / m ^{2 of} the paper base material, a paper base material, a heat seal sheet, and a medicine were prepared in the same manner as in Example 2. PTP was manufactured sequentially.

<Example 4>
In the production of the paper base material of Example 2, except that the basis weight of the base paper was increased and the basis weight of the paper base material was set to 40 g / m ² , the paper base material, the heat seal sheet, and the medicine were prepared in the same manner as in Example 2. PTP was manufactured sequentially.

<Example 5>
In the production of the paper base material of Example 2, except that the basis weight of the base paper was increased to make the basis weight of the paper base material 55 g / m ² , the paper base material, the heat seal sheet, and the chemical were used in the same manner as in Example 2. PTPs were manufactured sequentially.

<Example 6>
In the production of the paper base material of Example 1, the coating amount after drying on one side of the coating material for coating layer (A) was 3.0 g / m ² (6.0 g / m ^{2 on} both sides), A paper substrate, a heat-sealing sheet, and a drug-containing PTP were sequentially produced in the same manner as in Example 1 except that the basis weight of the base paper was reduced so that the amounts became the same as in Example 1.

<Comparative Example 1>
In the manufacture of the paper base material of Example 1, the irregular freeness of the pulp was set to 770 mL (normally 380 mL as freeness), and the coating amount after drying on one side of the coating material for coating layer (A) was 1.1 g / m ² (both sides). 2.2 g / m ² ), and the paper base material, the heat seal sheet and the chemical were prepared in the same manner as in Example 1 except that the basis weight of the base paper was reduced so that the basis weight of the paper base material was the same as in Example 1. PTPs were manufactured sequentially.

<Comparative Example 2>
In the manufacture of the paper base material of Example 1, the coating material for the coating layer (A) was not applied, and the basis weight of the base paper was increased so that the basis weight of the paper base material was the same as in Example 1. In the same manner as in Example 1, a paper substrate, a heat seal sheet, and a drug-containing PTP were sequentially manufactured.

<Comparative Example 3>
In the manufacture of the paper substrate of Example 1, the coating amount after drying of one side of the paint coating layer (A) and ^{0.05g / m 2 (0.1g / m} 2 on both sides), the basis of the paper substrate A paper substrate, a heat seal sheet, and a chemical-containing PTP were sequentially produced in the same manner as in Example 1 except that the basis weight of the base paper was increased so that the amounts became the same as in Example 1.

<Comparative Example 4>
In the production of the paper base material of Example 2, the coating amount after drying on one side of the coating material for coating layer (A) was 1.1 g / m ² (2.2 g / m ^{2 on} both sides), and the basis weight of the base paper was A paper substrate, a heat seal sheet, and a drug-containing PTP were sequentially manufactured in the same manner as in Example 2, except that the basis weight of the paper substrate was reduced to 14 g / m ² .

<Comparative Example 5>
In the production of the paper base material of Example 1, a paper base material and a heat seal sheet were prepared in the same manner as in Example 1 except that the following coating material for coating layer (B) was used instead of the coating material for coating layer (A). And a drug-containing PTP were sequentially produced.
Coating material for coating layer (B): 4% by mass aqueous solution of polyvinyl alcohol (trade name: PVA117, manufactured by Kuraray Co., Ltd.).

<Comparative Example 6>
In the production of the paper base material of Example 1, the following coating layer coating material (C) was used in place of the coating layer coating material (A), and the coating amount after drying on one side was 0.8 g / m ² (both sides). 1.6 g / m ² ), and except that the basis weight of the base paper was reduced so that the basis weight of the paper base material was the same as in Example 1, the paper base material, the heat seal sheet, and Drug-loaded PTPs were manufactured sequentially.
Coating material for coating layer (C): 8% by mass aqueous solution of hydrophobized starch (trade name: GRS-T110, manufactured by Oji Cornstarch).

Table 1 shows the irregular freeness of the pulp, the basis weight of the base paper, the type of the coating for the coating layer applied to the base paper and the coating amount per one side (after drying), and the paper in Examples 1 to 6 and Comparative Examples 1 to 6, respectively. The basis weight and the density of the substrate are shown, respectively.
In each example, the coating amount per one side of the coating material for the coating layer (the coating amount after drying) was determined based on the amount of the water-soluble polymer (anionic polyacrylamide resin, polyvinyl alcohol or hydrophobic starch) in the coating material for the coating layer. Equal to the amount applied.

<Evaluation>
The following evaluations were performed on the heat-sealing sheets (lid material with a heat-adhesive layer) and the PTPs containing the chemicals obtained in Examples 1 to 6 and Comparative Examples 1 to 6, and the results are shown in Table 2.

[Measurement of burst strength]
The burst strength (kPa) of the heat seal sheet of each example was measured using a burst tester (model: MD200, manufactured by Kumagaya Riki Kogyo Co., Ltd.) according to ISO2758.

[Measurement of peel strength and evaluation of substrate destruction state]
A flange portion of the PTP obtained in the production of the above-mentioned drug-containing PTP was cut to a width of 15 mm to prepare a peel strength measurement sample.
The peel strength (N / m) of the obtained sample was measured using a tensile tester (model: Tensilon RTC1250A, manufactured by Orientec Co., Ltd.) according to JIS P 8113: 2006. The end of each material was chucked and measured at a peeling speed of 300 mm / min by a 180 ° peel method.
In the measurement of the peel strength, the state of breakage of the base material of the cover material was visually checked and evaluated according to the following criteria.
(Evaluation criteria for the state of substrate destruction during the peel test)
：: Substrate destruction did not occur.
Δ: The lid material could be peeled off, but paper pieces and fluff adhered to the polyvinyl chloride resin film.
×: Destruction of the substrate occurred.

[Measurement of drug pushing force]
The heat-sealing sheet of each example and the polyvinyl chloride resin film for a container (a pocket is not formed) in which a hole having a diameter of 10 mm has been previously formed are brought into contact with the surface of the heat-sealing sheet on the side of the heat bonding layer with the polyvinyl chloride resin film. Then, using a hot press tester, a thermocompression bonded product was prepared under the thermocompression bonding conditions of 150 ° C., 3.0 kgf / cm ² , and 1.1 seconds.
Next, using a texture analyzer (model: TA-XT plus, manufactured by Eiko Seiki Co., Ltd.), a polycarbonate resin plate (10 cm × 10 cm, thickness 30 mm) having a hole having a diameter of 20 mm was formed. It was set so as to overlap the center of the columnar probe.
Next, on the resin plate, the center of the hole formed in the polyvinyl chloride resin film of the thermocompression-bonded product is located at the center of the hole of the resin plate, and the polyvinyl chloride resin film is on the top. Set to
Next, a drug (tablet diameter: 9.5 mm, thickness: 4 mm) was attached to the tip of the cylindrical probe of the texture analyzer, and the probe was lowered at a descent speed of 300 mm / min. Extrusion force) (N) was measured. The medicine pushing force is a force required for the medicine at the tip of the probe to push through the thermal bonding layer and the cover material of the PTP and to be pushed out below the PTP. The smaller the medicine pushing force, the better the press-through suitability. It is considered that the force that can be pushed out is about 18 N or less.

[Sensory evaluation of press-through suitability and easy peel suitability]
The obtained drug-containing PTP was actually subjected to a sensory evaluation of press-through property and easy peel suitability based on the following criteria.
(Press-through suitability)
：: The drug was pushed out without any problem.
'': It took a little power to push out the drug.
Δ: Great force was required to push out the drug.
×: The drug was not extruded because the lid material was too strong. Alternatively, the lid material was peeled off before pushing out the medicine.
(Easy peel suitability)
：: Easy peeling of the lid material was possible without any problem.
Δ: Easy peeling of the lid material was observed, but sticking of paper chips and fluff was observed on the container side.
X: The base material was broken and easy peeling was not possible.

  In Table 2, "-" in the column of peel strength indicates that the peel strength could not be measured because the substrate was broken.

As shown in the above results, the drug-containing PTPs of Examples 1 to 6 had a small peel strength in the peel test. Further, no destruction of the substrate was observed during the peeling test, and the same results were obtained in the actual sensory evaluation performed on the PTP containing the drug. From these results, it was confirmed that they were excellent in easy peel suitability.
In addition, the heat-sealing sheets used in Examples 1 to 6, particularly the PTPs containing Examples 1 to 3 and 6, had a small drug pushing force. The drug pushing force almost corresponded to the burst strength. In addition, in the actual sensory evaluation performed on the PTP containing the drug, the drug could be pushed out without any problem.
From these results, it was confirmed that the drug-containing PTPs of Examples 1 to 6 have excellent easy peel suitability and press-through suitability.

  On the other hand, in the heat seal sheets of Comparative Examples 1 to 6, the peel strength was not measurable in the peel test, or the peel strength was higher than those of Examples 1 to 6 even though the peel strength could be measured. Further, at the time of the peeling test, destruction of the base material, fluffing of the surface, and peeling of the paper piece were observed, and the same results were obtained in the actual sensory evaluation performed on the PTP containing a drug.

DESCRIPTION OF SYMBOLS 1 Container 3 Lid material 5 Thermal adhesive layer 10 Pharmaceutical PTP (press-through package)
15 Pocket part 17 Flange part 19 Drug 31 Paper base material

Claims (4)

With a container and a lid material, the container, in a drug press-through package having a pocket portion for containing a drug, and a flange portion joined to the lid material,
A heat bonding layer is provided between the lid member and the flange portion,
The cover material has a paper base, the paper base is a base paper made of pulp, and a coating layer containing a polyacrylamide resin provided on at least the surface of the base paper on the heat bonding layer side, Including
The freeness of the pulp constituting the base paper measured according to JIS P 8121-2: 2012 is 600 mL or less;
The content of the polyacrylamide resin in the coating layer provided on the surface on the side of the heat bonding layer is 0.1 to 10.0 g / m ² ,
Ri der basis weight of 18 g / ^{m 2} or more of the paper substrate,
The container is a molded article of the container base sheet,
The container base sheet is a transparent thermoplastic resin sheet, wherein (a) a polypropylene sheet, (b) a polyvinyl chloride sheet, (c) a cyclic polyolefin sheet, and (d) any of the above (a) to (c). (E) one or two or more sheets selected from the group consisting of (a) to (d) above, wherein (e) one or more sheets selected from the group consisting of (a) to (d) are selected from polyvinylidene chloride, polychlorotrifluoroethylene and polyethylene. one or more agents for press through packaging a polymer sheet, wherein the sheet der Rukoto coated laminate or the polymer. The pharmaceutical press-through package according to claim 1, wherein the pulp constituting the base paper has the following irregular freeness of 50 to 500 mL.
Irregular freeness: Measured according to JIS P 8121-2: 2012 except that the solid content concentration of the pulp suspension was changed from 0.30% ± 0.01% to 0.030% ± 0.001%. Freeness. 3. The pharmaceutical press-through package according to claim 1, wherein the paper substrate has a basis weight of 50 g / m ² or less. The lid material can be peeled from the container by the easy peel method, and when the lid material is peeled by the easy peel method, the thermal adhesive layer is peeled from the paper base at a portion in contact with the flange portion. The pharmaceutical press-through package according to any one of claims 1 to 3 , wherein the lid member and the flange portion are bonded together so as to remain on the flange portion side.

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